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An exploratory study on the clinical correlation between DNA ploidy analysis, TCT, gene methylation detection and pathological classification of potential oral malignant lesions and their role in disease monitoring

An exploratory study on the clinical correlation between DNA ploidy analysis, TCT, gene methylation detection and pathological classification of potential oral malignant lesions and their role in disease monitoring

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100054816
Enrollment
Unknown
Registered
2021-12-27
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral potentially malignant disorders

Interventions

Gold Standard:Histopathological examination
Index test:DNA&#32
ploidy&#32
analysis,&#32
TCT,&#32
gene&#32
methylation&#32
detection

Sponsors

Affiliated Stomatological Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with oral erythema, oral leukoplakia, oral lichen planus, oral submucosal fibrosis and other potential oral malignant lesions, as well as squamous cell carcinoma, were clinically and pathologically diagnosed without abnormal hyperplasia and accompanied by mild, moderate and severe abnormal hyperplasia of mucosal epithelium; 2. Male or female aged 18-85; 3. There is no obvious inflammation in the local area, no residual root, residual crown, sharp tooth tip, bad prosthesis, cheek and lip bite and other stimuli; 4. Not treated with hormone, laser, radiation or chemical drugs; 5. Being able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Those with severe heart, lung, liver, kidney and other systemic diseases. 3. Other tumors and mentally ill patients.

Design outcomes

Primary

MeasureTime frame
Cellular morphologic change;DNA index;Gene methylation differential score;—

Countries

China

Contacts

Public ContactHong Yun

Affiliated Stomatological Hospital of Sun Yat-Sen University

hongjun5@mail.sysu.edu.cn+86 13512766931

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026